Regulations Governing Promotion, Advertisement and Marketing of regulated 
products  
 
 
Doc. Ref. No.:  CBD/TRG/017 Rev_ 1   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REGULATIONS  GOVERNING PROMOTION , 
ADVERTISEMENT AND MARKETIN G OF REGULATED 
PRODUCTS  
 
(Rwanda FDA law No 003/2018 of 09/02/2018  Article 8 ) 
 
 Regulations Governing Promotion, Advertisement and Marketing of regulated 
products  
 
 
Doc. Ref. No.: CBD/TRG/017 Rev_ 1  Page 2 of 14 
 
 REGULATION DEVELOPMENT HISTORY  
  
DRAFT ZERO BY CO NSULTANTS  20th May 2018   
ADOPTION BY RWANDA FDA  18th September 2020  
STAKEHOLDERS ’ CONSULTATION  16th October 2020  
ADOPTION OF STAKEHOLDERS ’ COMMENTS  24 November 2020  
DATE FOR COMING INTO EFFECT  31st December 2020  
 
Document Revision Histor y 
Date of 
revision  Revision 
number  Changes made and/or reasons for revision  
18/06/2021  1 1. Provisions that require to sell, distribute or market  regulated 
products  by licensed or authorized personnel or establishment to 
authorized users ; 
2. Article and provisions on Marketing of Regulated products ; 
3. Provisions for administrative sanctions upon violation the 
regulations , sales, distributes, market and/or influence the 
inappropriate use of regulated products;  
4. Provisions on marketin g aspect  of regulated products in different 
articles of the regulations;  
5. The table revision history was included . 
 
 
 
 
 
 
 
 
  Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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ADOPTION AND APPROVAL OF THE REGULATIONS  
 
In EXERCISE of the powers conferred upon Rwanda Food and Drugs Authority  by Article 8 of 
the Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its mission, 
organization and functioning , hereby ADOPTS and ISSUES these regulations No CBD/ TRG/017  
Governing the Promotion , Advertisement and Marketing of regulated products , made this 23rd 
day of July, 2021 . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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TABLE OF CONTENTS  
REGULATION DEVELOPME NT HISTORY  ................................ ................................ ..............  2 
DOCUMENT REVISION HI STORY ................................ ................................ ..............................  2 
ADOPTION AND APPROVA L OF THE REGULATIONS ................................ .........................  3 
TABLE OF CONTENTS  ................................ ................................ ................................ ..................  4 
CHARPTER I: GENERAL PROVISIONS  ................................ ................................ ....................  6 
ARTICLE ONE: PURPOSE OF THESE REGU LATIONS  ................................ ................................ .............  6 
ARTICLE 2: CITATION  ................................ ................................ ................................ .......................  6 
ARTICLE 3: APPLICATION  ................................ ................................ ................................ .................  6 
ARTICLE 4: DEFINITIONS  ................................ ................................ ................................ ...................  6 
CHAPTER II: PROMOTIO N, ADVERTISMENT AND MARKETING OF REGULAT ED 
PRODUCTS ................................ ................................ ................................ ................................ ........  8 
ARTICLE 5: CONDITIONS FOR PROMOT ING, ADVERTISING AND MAR KETING OF REGULATED 
PRODUCTS  ................................ ................................ ................................ ................................ .........  8 
ARTICLE 6: CONTENT OF PROMOTIONA L MATERIALS  ................................ ................................ ........  8 
ARTICLE 7: PROHIBITIONS AND RESTRICTIONS  ................................ ................................ ..................  9 
ARTICLE 8: FALSE OR MISLEADING P ROMOTIONAL ADVERTISE MENTS  ................................ ..............  9 
ARTICLE 9: COMPARATIVE PROMOTION  ................................ ................................ ..........................  10 
ARTICLE 10: APPLICATION FOR PROMO TION OR ADVERTISEMEN T OF REGULATED PRODU CTS ........  10 
ARTICLE 11: APPROVAL FOR PROMOTIO N OR ADVERTISEMENT O F REGULATED PRODUCTS  ............  10 
ARTICLE 12: VALIDITY OF APPROVAL  ................................ ................................ .............................  11 
ARTICLE 13: WITHDRAWAL OF APPROVA L ................................ ................................ ......................  11 
ARTICLE 14: REGULATION OF MEDICAL REPRESENTATIVE FOR RE GULATED PRODUCTS  ................  11 
ARTICLE 15: IMPORTATION OF PROMOT IONAL MATERIALS  ................................ .............................  11 
ARTICLE 16: PROMOTION AND ADVERTI SEMENT AUTHORIZATION  TIMELINES  ................................  12  Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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ARTICLE 17: MARKETING OF REGULATED PRODUCTS  ................................ ................................ ..... 12 
CHAPTER III: MISCELL ANEOUS PROVISIONS  ................................ ................................ ... 13 
ARTICLE 18: POWER TO ISSUE GUIDEL INES ON PROMOTION , ADVERTISEMENT AND M ARKETING  .... 13 
ARTICLE 19: LANGUAGES  ................................ ................................ ................................ ...............  13 
ARTICLE 20: ADMINISTRATIVE SANCTIONS  ................................ ................................ ....................  13 
ARTICLE 21: APPEALS TO THE AUTHOR ITY ................................ ................................ .....................  13 
ARTICLE 22: COMMENCEMENT  ................................ ................................ ................................ ....... 14 
 
   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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CHARPTER I: GENERAL PROVISIONS  
Article One: Purpose of these regulations  
The purpose of these r egulations is to provide a legal framework for the effective and efficient 
control of the promotion and advertisement  of regulated products and providing an open, 
transparent and non -discrimin atory process for the application for approval of promotion , 
advertising  and marketin g of regulated products.  
Article 2: Citation  
These regulations may be cited as “Rwand a FDA Regulations Governing Promotion , 
Advertisement  and Marketin g of Regulated Products” 
Article 3: Application  
These regulations shall apply to all activities related to the advertisements or promotion  and 
marketin g of regulated  products that are manufactured , imported, distributed, stored, sold or used  in 
Rwanda.  
Article 4: Definitions  
In these regulations, unless the context otherwise requires;    
1. “Advertisement ” means a form of communication through the media about products, 
services or  ideas by an identified sponsor which is used to encourage, persuade or manipulate 
an au dience  (viewers, readers or listeners)  to continue with or take some new action .  
2. “Advertising ” means  anything that is aimed or designed to promote the supply, sale or use 
of a product whether or not for financial gain, and it includes  but not limited to  written 
communication materials (for instance a notice, circular, handouts,  wrappers, catalogues, bill 
boards, posters, newspapers, magazines, digital and social media  posters  or other 
promotional document) , oral and  an audio  materials  (records, tapes, radio , …) and visual 
announcement  (films, video recordings, television, internet, electronic media, interactive data 
systems,…) . 
3. “Appropriate fee ” means the fee prescribed in the Regulations No CBD/TRG/004 related to 
regulatory service tariff/fees and fine s. 
4. “Authority ” means Rwanda Food and Drugs Authority, Rwanda FDA . 
5. “Applicant ” means any advertisement agent, distributor, manufacturer or the sponsor of the 
advert . 
6. “General public ” means any person considered as a client or potential client.  
7. “Law ” means Law No. 003/2018 of 09/02/2018 establishing Rwanda FDA and determining 
its mission, organization and functioning.   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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8. “Marketing” means to promote, distribute, sell, or advertise regulated  product s, or/ and 
creating a relationship of  the public  and/or with information services  regard to regulated 
products . 
9. “Media”  means newspaper, magazine, medical/journal, television, radio, the Internet; Out of 
home, vehicle branding, posters, handbills, cinema, point of sale material; online, digital and 
social media, any  form of projected light and sound recordings or any of such means of 
communication.  
10.  “Misleading information ” means information  that gives a wrong idea or impression  
11.  “Promotion ” is any communication that attempts to influence people to buy or use the 
regulated products. It i s the publicizing of a product so as to increase public awareness or 
sales using of audio -visual , oral  or written material  through advertising, sales promotion, 
direct marketing publicity, trade shows, promotional meetings,  particip ation in exhibitions , 
giving samples, personal selling, etc .  
12. “Promotional material ” means any representation concerning the attributes of a product 
conveyed by any means whatsoever for the purpose of encouraging the usage of the product.  
13. “Regulated produc t” means processed foods, pharmaceutical products, vaccines, human 
and veterinary processed foods and other biological products used in clinical as drugs, food 
supplements, food fortificant , fortified foods, poisonous substances, herbal medicines, 
medicated cosmetics, medical devices, tobacco and tobacco products.  
14. “Pharmaceutical product ” means  any substance capable of preventing, treating human or 
animal diseases and any other substance intended for administration to a human being or an 
animal in o rder to diagnose diseases, restore, correct or carry out modification of organic or 
mental functions. It also means products used in disinfecting premises in which food and 
drugs are manufactured, prepared or stored, cleaning hospitals, and equipment  and f arm 
houses . 
 
   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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CHAPTER II: PROMOTION, ADVERTISMENT AND MARKETIN G OF REGULATED 
PRODUCTS  
Article 5: Conditions  for promoting , advertising and marketin g of regulated p roduct s  
(i) It is prohibited to advertise, promote or/and marke t any regulated products  unless  it is 
registered by the Authority . 
(ii) It is prohibited to advertise  or promote any regulated product unless the advertisement  or 
promotion  has the clearance and approval issued by the Authority . 
(iii)  It is prohibited to  carry out regulated product launch unless a written prior approval or 
clearance by the Authority has been received . 
(iv) It is prohibited to promote , advertise  or marke t a regulated product in a manner that is , 
directly or by implication , misleading or calculated to mislead the population . 
(v) All packaging and labelling materials shall provide information which is consistent with 
product  information approved during the registration of the product.  
(vi) All promotional materials shall have a disclaimer owning all claims stated in the materials 
as well as disowning claims by third parties on any additional information regarding the 
product.  
(vii) It is prohibited to sell or distributed regulated products, create public product relationship 
or information services for non -authorized user s.   
Article 6 : Con tent of promotional materials  
(i) Promotional advertisements shall be accurate, unbiased, complete, clear and designed to 
promote credibility and trust by the general public and health  care providers .  
(ii) Promotional advertisements shall be consistent with the approved product information. 
The promotion shall be in line with conditions or illnesses for which it has been 
registered.  
(iii) Promotional material shall not contain misleading or unverifiable statements or omissions 
regarding quality, safety and efficacy or value which likely induce product use or give rise 
to undue risks.  
(iv) A promotional aid (note pads, calendars and other such items) shall be limited to bear 
names of products currently registered in Rwanda.  
(v) Advertisements  which unfairly undermine any product  of a competitor, either directly or 
by implication  are prohibited .  
(vi) Promotion shall not suggest either directly or by implication that one product is superior 
(or equivalent) to another identifiable treatment or product .  
(vii)  Promotional advertisements for a  product shall present information that is reasonably 
balanced between side effects and contra -indications and efficacy and safety. Promotions  Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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should not state or imply that a product is “safe”, is “100% safe”, has “no side effects” or 
that its “use will n ot cause harm”.  
(viii) Promotional advertisements should not in any way discourage the public from seeking the 
advice of a healthcare provider.  
Article 7: Prohibitions and restrictions  
(i) It is restricted for every  person to promote or advertise or carry out any pr omotional 
activities of regulated products, prior to  obtaining written approval from the Authority ; 
(ii) Promotion of regulated products to the public in open markets, bus stands and moving 
vehicles such as buses or any other public transport is not permitted unless approved by 
the Authority ;  
(iii) The displaying of a poster for a specific regulated product in a public place, e.g. at 
hospitals, clinics, shops or anywhere shall be considered as promotional material 
targeting the general public and is therefore subjec t to approval by the Authority ; 
(iv) An advertisement to the general public shall not refer to the  provisions of this 
regulations,  the Authority or any employee of the Authority ; 
(v) Any language that brings or is likely to mislead or deceive or create fear or dist ress to 
individuals or community is prohibited ; 
(vi) Any advertisement which uses words such as “Number one product”, “the best product” 
or any such words in promoting a product are hereby prohibited.  
(vii) Any product advertisement which may induce or attract childr en to use any  regulated  
product is prohibited ;  
(viii) Medicines and tobacco products shall  not be promoted beyond determined 
circumstance s; 
(ix) An advertisement shall not imply that if the reader, viewer or listener is suffering from 
any ailment or disease, he /she shall suffer more severely from the illness, ailment or 
disease on failure to use that particular drug product;  
(x) An advertisement shall not over -dramatize any symptoms by way of drawing a picture ;  
(xi) An advertisement shall not denigrate or attack unfairly an y competitive products ; 
(xii)  Breast Milk substitutes shall not be promoted and/or marketed beyond provisions of the 
Law regulating marketing  of breast milk  substitutes.  
Article 8 : False or misleading promotional advertisements  
(i) No person shall promote , advertise  or market  any regulated product in a manner that is 
false, misleading or deceptive or is likely to create an erroneous impression regarding its 
character, value, quantity, composition, merit, safety or efficacy as the case may be.  
(ii) Any promotiona l advertisement that imitate s the general layout, text slogans, or visual 
presentation or devices of other advertisements from other companies in a way likely to 
mislead, deceive or confuse the consumer  shall be considered false and misleading .   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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(iii) Any promotional advertisement framed in such a manner as to exploit the belief system of 
and/or induce fear in the consumer to purchase the product  shall be considered false and 
misleading;   
(iv) Any promotional advertisement that contain s the words ‘magic’, ‘mirac le’ or mystical’. 
Exotic descriptions such as ‘super potency’ or such other words as to induce daily and 
continuous use of the product  shall be considered false and misleading;   
Article 9 : Comparative promotion  
(i) Comparison of regulated products for competit ion purposes is prohibited.  
(ii) Promotion or advertisement that unfairly criticise  any company of its competitive 
products either directly, indirectly or by implication  are be prohibited .  
(iii) Comparison of new version of the same products shall be factual, fair, reflects the body 
of evidence and does not mislead by distortion, by undue emphasis or in any other way;  
(iv) For promotion of drugs, only molecules can be compared but not brands.  
(v) Hinging comparatives; those which merely claim that a product is better, stronger, more 
widely prescribed is prohibited  
Article 10 : Application for  promot ion or advertise ment of  regulated products  
An application to promote or advertise a regulated product  shall be prepared in  accordance with 
requirements as provided in the relevant guidelines on promotion and advertisement of regulated 
products . 
Article 11 : Approval for promotion or advertisement of regulated products  
(i) The final version of the advertisement in whatsoever form shall be submitted for vetting 
before final publication ; 
(ii) Advertisements considered acceptable by the Authority will be communicated in writing 
to the applicant with a clear indication of the unique reference number for each 
advertisement, issued by the Authority ; 
(iii) Advertisements considered unacceptab le by the Authority will be communicated in 
writing to the applicant with clear clarification on the unacceptable information or 
illustration and on the ruling thereof ;  
(iv) Any alterations in the format of the approved advertisement without express written 
permission of the Authority will render the approval null and void and shall attract fines as 
provided for in the Regulations related to regulatory service tariff/fees and fines currently 
enforced ; 
(v) Notwithstanding the above, the Authority reserves the right to revoke approval of an 
advertisement as the result of new evidence concerning product or public safety or product 
efficacy or quality.   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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Article 12 : Validity of approval  
The duration of approval of an advertisement shall be two (2) years for drugs and high risk foods 
and five (5) years for other products . 
Article 13 : Withdrawal of approval  
The Authority shall withdraw the approval for an advertisement or promotion if:  
(i) the grounds on which the approval was granted was later fou nd to be false or incomplete ; 
(ii) any of the conditions under which the approval was granted has been contravened, or ; 
(iii) in the light of new scientific evidence against claims contained in the advertisement . 
Article 14 : Regulation of Medical Representative for regulated products  
(i) Any person , prior to  exercis ing as medical representative of regulated product , shall have 
an authorization issued by the Authority ;  
(ii) The medical representative shall possess minimum qualification of A1 in medical  science 
(Pharmaceutica l, Medicine and Surgery, Veterinary medicine, Nursing and Midwife, 
Dental therapy/Surgery, Clinical medicine, Anaesthesia, Ophthalmology , Laboratory, Bio -
Medical Engineering, Clinical psychology, Public health ) or life sciences  (Bio-Technology, 
Biology, Chemistry, Microbiology… ) from recognized institution with relevant experience  
and/o r trainings in matters related  to medicines .  
(iii) The requirements for registration of medical representative shall be detailed in relevant 
guidelines . 
(iv) During promotion , advertisement  or marketing of regulated product, the  medical 
representatives shall fulfil  their basic function as opportunities to provide  unbiased 
scientific  information  to prescribers and dispensers . 
Article  15: Importation of promotional materials  
(i) Any person who imports p romotional sample s shall also comply to regulations . 
(ii) Importation of promotional materials require an import licence . However, it is not subject 
to importation fee .  
(iii) The importer may apply for approval of promotional materials before importing them by 
submitting the mock -up or design  to the Authority  for review.   Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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Article 1 6: Promotion and advertisement authorization timelines  
The review process of promotion and advertisement application by the Authority shall not exceed 
10 working days upon compliance with all requirements.  
Article 1 7: Marketing of Regulated products  
(i) Regulated products sh all be marketed by authorized personnel and at authorized 
establishments.  
(ii) Medicines, breast -milk substitute, and food supplement  products shall be  dispensed up on 
prescription of qualified medical doctor or other health care professionals  licensed to do 
so. Exception to this should be backed up with other regulations and guidelines.  
(iii) It is prohibited to sale or distribute regulated products to unauthorized user.  
(iv) It is prohibited to deploy marketing strategies such us pyramid schemes, setting quotas, 
providing incentives or bonus in accordance to the quantity of sales and others that 
influence increased use of a particular regulated product in a specifically targeted 
population group or general public.  
(v) It is prohibited for medical doctors, pharmacists or other health care professionals to 
promote  or influence  excessive or inappropriate  use of a certain regulated product for the 
sake of financial ga ins or driven by other personal of interest s.  
(i) Any person who sales, distribute or market regulated products in the manners that 
contradict with provisions of this regulations shall be sanctioned with Administrative fines 
as prescribed in the Authority Reg ulations No CBD/TRG/004 related to regulatory service 
tariff/fees and fines.  
 
 
 
 
 
 
 
 
 
 
  Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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CHAPTER III: MISCELLANEOUS PROVISIONS   
Article 1 8: Power to issue guidelines on promotion , advertisement and marketing  
The A uthority shall issue guidelines, Standards Operating procedures (SOPs), forms necessary for 
the implementation of these r egulations .  
Article 1 9: Languages  
All promotion and advertisement application and supporting documents shall be presented in at 
least one of the official language used in Rwand a.  
Article 20: Administrative Sanction s 
Any person who contravenes any of the provisions of these r egulations shall be guilty of an offence 
under these Regulations  and shall be liable to any of the administrative sanctions and penalties as 
stipulated in the regulation s related to regulatory service tariff/ fees and fines issued by the 
Authority . 
(ii) Upon violation of these Regulations, any person who advertises regulated products will be 
sanctioned with a written warning on the  first time  of the violation . 
(iii) A person who violates any of the provisions of these regulations for the second time  or 
alters the previously approved promotional material  shall be sanctioned with 
Administrative fines  as prescribed in the Authority Regulations No CBD/TRG/004 related 
to regulatory service tariff/fees and fines.  
(iv) Any person who displays a promotional material in any form that was not previously 
approved by the Au thority shall be sanctioned with  administrative fine . 
(v) Any person who violated the Regulations , sales, distributes , market and/or influence the 
used of regulated products in manners that are different to provisions of regulation shall be 
sanctioned  administratively  as prescribed in the Authority Regulations No CBD/TRG/004 
related to regulatory service tariff/fees and fines.  
(vi) Repeated offense shall lead to de -registration  of the product.  
Article  21: Appeals to the authority  
Any person aggrieved by a decision of the Authority may apply to the Authority for review of the 
decision showing grounds for dissatisfaction within thirty (30)  working  days from the date of 
notice.  
 
The Authority shall, within fifteen (15) working days from the date of receiving the application, 
review, reject or vary its own decision.  
  Regulations Governing the Promotion, Advertisement and Marketing of 
regulated products  
 
 
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However, if after reconsideration of the application, the Authority still rejects the application,  the 
applicant shall appeal to the Board of Directors.  
Article 22: Commencement   
This regulation shall enter into force on date of its signature and publicati on. All prior contrary 
provisions to these regulations are hereby repealed.  
 
End of Document